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    Focal laser ablation as clinical treatment of prostate cancer: Report from a Delphi consensus project
    (Springer Verlag, 2019) van Luijtelaar, Annemarijke; Greenwood, Bernadette Marie; Ahmed, Hashim Uddin; Barqawi, Al Baha; Barret, Éric; Bomers, Joyce G.R.; Brausi, Maurizio; Choyke, Peter L.; Cooperberg, Matthew R.; Eggener, Scott E.; Feller, John Francis; Frauscher, Ferdinand; George, Arvin Koruthu; Hindley, Richard Graham; Jenniskens, Sjoerd F.M.; Klotz, Laurence; Kovacs, Gyoergy; Lindner, Uri; Loeb, Stacy; Margolis, Daniel Jason Aaron; Marks, Leonard S.; May, Stuart; McClure, Timothy D.; Montironi, Rodolfo; Nour, Sherif Gamal; Oto, Aytekin; Polascik, Thomas James; Rastinehad, Ardeshir R.; de Reyke, T. M.; Reijnen, Jeroen Sebastiaan; de la Rosette, Jean J. M. C. H.; Sedelaar, John Pieter Michiel; Sperling, Dan S.; Walser, Eric M.; Ward, John F.; Villers, Arnauld A.; Ghai, Sangeet; Fütterer, Jürgen Jacobus
    Purpose: To define the role of focal laser ablation (FLA) as clinical treatment of prostate cancer (PCa) using the Delphi consensus method. Methods: A panel of international experts in the field of focal therapy (FT) in PCa conducted a collaborative consensus project using the Delphi method. Experts were invited to online questionnaires focusing on patient selection and treatment of PCa with FLA during four subsequent rounds. After each round, outcomes were displayed, and questionnaires were modified based on the comments provided by panelists. Results were finalized and discussed during face-to-face meetings. Results: Thirty-seven experts agreed to participate, and consensus was achieved on 39/43 topics. Clinically significant PCa (csPCa) was defined as any volume Grade Group 2 [Gleason score (GS) 3+4]. Focal therapy was specified as treatment of all csPCa and can be considered primary treatment as an alternative to radical treatment in carefully selected patients. In patients with intermediate-risk PCa (GS 3+4) as well as patients with MRI-visible and biopsy-confirmed local recurrence, FLA is optimal for targeted ablation of a specific magnetic resonance imaging (MRI)-visible focus. However, FLA should not be applied to candidates for active surveillance and close follow-up is required. Suitability for FLA is based on tumor volume, location to vital structures, GS, MRI-visibility, and biopsy confirmation. Conclusion: Focal laser ablation is a promising technique for treatment of clinically localized PCa and should ideally be performed within approved clinical trials. So far, only few studies have reported on FLA and further validation with longer follow-up is mandatory before widespread clinical implementation is justified.
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    Molecular biomarkers in the context of focal therapy for prostate cancer: Recommendations of a delphi consensus from the focal therapy society
    (Edizioni Minerva Medica, 2022) Marra, Giancarlo; del Pilar Laguna Pes, Maria; Walz, Jochen; Pavlovich, Christian P.; Bianco, Fernando; Gregg, Justin; Lebastchi, Amir H.; Lepor, Herbert; Macek, Petr; Rais-Bahrami, Soroush; Robertson, Cary; Rukstalis, Daniel; Salomon, Georg; Ukimura, Osamu; Abreu, Andre L.; Barbe, Yann; Cathelineau, Xavier; Gandaglia, Giorgio; George, Arvin K.; Gomez Rivas, Juan; Gupta, Rajan T.; Lawrentschuk, Nathan; Kasivisvanathan, Veeru; Lomas, Derek; Malavaud, Bernard; Margolis, Daniel; Matsuoka, Yoh; Mehralivand, Sherif; Moschini, Marco; Oderda, Marco; Orabi, Hazem; Rastinehad, Ardeshir R.; Remzi, Mesut; Schulman, Ariel; Shin, Toshitaka; Shiraishi, Takumi; Sidana, Abhinav; Shoji, Sunao; Stabile, Armando; Valerio, Massimo; Tammisetti, Varaha S.; Phin Tan, Wei; van Den Bos, Willemien; Villers, Arnaud; Willemse, Peter-Paul; de la Rosette, Jean J. M. C. H.; Polascik, Thomas; Sanchez-Salas, Rafael
    BACKGROUND: Focal therapy (FT) for prostate cancer (PCa) is promising. However, long-term oncological results are awaited and there is no consensus on follow-up strategies. Molecular biomarkers (MB) may be useful in selecting, treating and following up men undergoing FT, though there is limited evidence in this field to guide practice. We aimed to conduct a consensus meeting, endorsed by the Focal Therapy Society, amongst a large group of experts, to understand the potential utility of MB in FT for localized PCa. METHODS: A 38-item questionnaire was built following a literature search. The authors then performed three rounds of a Delphi Consensus using DelphiManager, using the GRADE grid scoring system, followed by a face-to-face expert meeting. Three areas of interest were identified and covered concerning MB for FT, 1) the current/present role; 2) the potential/future role; 3) the recommended features for future studies. Consensus was defined using a 70% agreement threshold. RESULTS: Of 95 invited experts, 42 (44.2%) completed the three Delphi rounds. Twenty-four items reached a consensus and they were then approved at the meeting involving (N.=15) experts. Fourteen items reached a consensus on uncertainty, or they did not reach a consensus. They were re-discussed, resulting in a consensus (N.=3), a consensus on a partial agreement (N.=1), and a consensus on uncertainty (N.=10). A final list of statements were derived from the approved and discussed items, with the addition of three generated statements, to provide guidance regarding MB in the context of FT for localized PCa. Research efforts in this field should be considered a priority. CONCLUSIONS: The present study detailed an initial consensus on the use of MB in FT for PCa. This is until evidence becomes available on the subject.
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    Primary whole-gland ablation for the treatment of clinically localized prostate cancer: A focal therapy society best practice statement
    (Elsevier, 2023) Deivasigamani, Sriram; Kotamarti, Srinath; Rastinehad, Ardeshir R.; Salas, Rafael Sanchez; de la Rosette, Jean J. M. C. H.; Lepor, Herbert; Pinto, Peter; Polascik, Thomas J.
    Context: Whole-gland ablation is a feasible and effective minimally invasive treatment for localized prostate cancer (PCa). Previous systematic reviews supported evidence for favorable functional outcomes, but oncological outcomes were inconclusive owing to limited follow-up. Objective: To evaluate the real-world data on the mid- to long-term oncological and functional outcomes of whole-gland cryoablation and high-intensity focused ultrasound (HIFU) in patients with clinically localized PCa, and to provide expert recommendations and commentary on these findings. Evidence acquisition: We performed a systematic review of PubMed, Embase, and Cochrane Library publications through February 2022 according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. As endpoints, baseline clinical characteristics, and oncological and functional outcomes were assessed. To estimate the pooled prevalence of oncological, functional, and toxicity outcomes, and to quantify and explain the heterogeneity, random-effect meta-analyses and meta-regression analyses were performed. Evidence synthesis: Twenty-nine studies were identified, including 14 on cryoablation and 15 on HIFU with a median follow-up of 72 mo. Most of the studies were retrospective (n = 23), with IDEAL (idea, development, exploration, assessment, and long-term study) stage 2b (n = 20) being most common. Biochemical recurrence–free survival, cancer-specific survival, overall survival, recurrence-free survival, and metastasis-free survival rates at 10 yr were 58%, 96%, 63%, 71–79%, and 84%, respectively. Erectile function was preserved in 37% of cases, and overall pad-free continence was achieved in 96% of cases, with a 1-yr rate of 97.4–98.8%. The rates of stricture, urinary retention, urinary tract infection, rectourethral fistula, and sepsis were observed to be 11%, 9.5%, 8%, 0.7%, and 0.8%, respectively. Conclusions: The mid- to long-term real-world data, and the safety profiles of cryoablation and HIFU are sound to support and be offered as primary treatment for appropriate patients with localized PCa. When compared with other existing treatment modalities for PCa, these ablative therapies provide nearly equivalent intermediate- to long-term oncological and toxicity outcomes, as well as excellent pad-free continence rates in the primary setting. This real-world clinical evidence provides long-term oncological and functional outcomes that enhance shared decision-making when balancing risks and expected outcomes that reflect patient preferences and values. Patient summary: Cryoablation and high-intensity focused ultrasound are minimally invasive treatments available to selectively treat localized prostate cancer, considering their nearly comparable intermediate- to long term cancer control and preservation of urinary continence to other radical treatments in the primary setting. However, a well-informed decision should be made based on one's values and preferences.
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    Role of multiparametric prostate MRI in the management of prostate cancer
    (Springer, 2021) O'Connor, Luke P.; Lebastchi, Amir H.; Horuz, Rahim; Rastinehad, Ardeshir R.; Siddiqui, M. Minhaj; Grummet, Jeremy; Kastner, Christof; Ahmed, Hashim U.; Pinto, Peter A.; Türkbey, Barış
    Introduction Prostate cancer has traditionally been diagnosed by an elevation in PSA or abnormal exam leading to a systematic transrectal ultrasound (TRUS)-guided biopsy. This diagnostic pathway underdiagnoses clinically significant disease while over diagnosing clinically insignificant disease. In this review, we aim to provide an overview of the recent literature regarding the role of multiparametric MRI (mpMRI) in the management of prostate cancer. Materials and Methods A thorough literature review was performed using PubMed to identify articles discussing use of mpMRI of the prostate in management of prostate cancer. Conclusion The incorporation of mpMRI of the prostate addresses the shortcomings of the prostate biopsy while providing several other advantages. mpMRI allows some men to avoid an immediate biopsy and permits visualization of areas likely to harbor clinically significant cancer prior to biopsy to facilitate use of MR-targeted prostate biopsies. This allows for reduction in diagnosis of clinically insignificant disease as well as improved detection and better characterization of higher risk cancers, as well as the improved selection of patients for active surveillance. In addition, mpMRI can be used for selection and monitoring of patients for active surveillance and treatment planning during surgery and focal therapy.
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    Standardized nomenclature and surveillance methodologies after focal therapy and partial gland ablation for localized prostate cancer: An international multidisciplinary consensus
    (Elsevier, 2020) Lebastchi, Amir H.; George, Arvin Koruthu; Polascik, Thomas J.; Coleman, Jonathan; de la Rosette, Jean J. M. C. H.; Türkbey, Barış; Wood, Bradford J.; Gorin, Michael A.; Sidana, Abhinav; Ghai, Sangeet; Tay, Kae Jack; Ward, John; Sanchez-Salas, Rafael; Muller, Berrend G.; Malavaud, Bernard; Mozer, Pierre; Crouzet, Sebastien; Choyke, Peter L.; Ukimura, Osamu; Rastinehad, Ardeshir R.; Pinto, Peter A.
    Background: Focal therapy (FT) and partial gland ablation (PGA) are quickly adopted by urologists and radiologists as an option for the management of localized prostate cancer.Objective: To find consensus on a standardized nomenclature and to define a follow-up guideline after FT and PGA for localized prostate cancer in clinical practice.Design, setting, and participants: A review of the literature identified controversial topics in the field of FT. Online questionnaires were distributed to experts during three rounds, with the goal to achieve consensus on debated topics. The consensus project was concluded with a face-to-face meeting in which final conclusions were formulated. Outcome measurements and statistical analysis: Controlled feedback of responses of previous rounds were summarized and returned to the participants allowing them to re-evaluate their decisions. The level of agreement to achieve consensus on a topic was set at 80%.Results and limitations: Sixty-five experts participated in this interdisciplinary consensus study (72% urologists; 28% radiologists). The experts propose the use of the herein standardized nomenclature for ablative procedures. After FT/PGA, the following tests should be performed to assess treatment outcomes: prostate-specific antigen (PSA), imaging, biopsies, and functional outcome assessment. Although not a reliable marker for treatment failure, PSA should be measured every 3 mo in the 1st year and every 6 mo thereafter. Magnetic resonance imaging is the preferred image modality and should be performed at 6 and 18 mo after treatment. A systematic 12-core transrectal ultrasoundguided biopsy combined with a targeted biopsy of the treated area should be performed 6-12 mo after treatment. Functional outcomes should be obtained 3-6 mo after treatment for the first time and until stability is attained.Conclusions: The panel recommends the use of the proposed nomenclature and follow-up protocols to generate reliable data supporting a broader implementation of FT as a standard of care for select patients with localized prostate cancer. Patient summary: In this report, we present expert opinion on the use of a standardized nomenclature, and surveillance methodologies after focal therapy and partial gland ablation for localized prostate cancer.
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    Utilization of focal therapy for patients discontinuing active surveillance of prostate cancer: Recommendations of an international delphi consensus
    (Elsevier Science Inc, 2021) Tan, Wei Phin; Rastinehad, Ardeshir R.; Klotz, Laurence; Carroll, Peter R.; Emberton, Mark; Feller, John F.; George, Arvin K.; Gill, Inderbir S.; Gupta, Rajan T.; Katz, Aaron E.; Lebastchi, Amir H.; Marks, Leonard S.; Marra, Giancarlo; Pinto, Peter A.; Song, Daniel Y.; Sidana, Abhinav; Ward, John F.; Sanchez-Salas, Rafael; de la Rosette, Jean J. M. C. H.; Polascik, Thomas J.
    Background: With the advancement of imaging technology, focal therapy (FT) has been gaining acceptance for the treatment of select patients with localized prostate cancer (CaP). We aim to provide details of a formal physician consensus on the utilization of FT for patients with CaP who are discontinuing active surveillance (AS). Methods: A 3-stage Delphi consensus on CaP and FT was conducted. Consensus was defined as agreement by >= 80% of physicians. An in-person meeting was attended by 17 panelists to formulate the consensus statement. Results: Fifty-six respondents participated in this interdisciplinary consensus study (82% urologist, 16% radiologist, 2% radiation oncology). The participants confirmed that there is a role for FT in men discontinuing AS (48% strongly agree, 39% agree). The benefit of FT over radical therapy for men coming off AS is: less invasive (91%), has a greater likelihood to preserve erectile function (91%), has a greater likelihood to preserve urinary continence (91%), has fewer side effects (86%), and has early recovery post-treatment (80%). Patients will need to undergo mpMRI of the prostate and/or a saturation biopsy to determine if they are potential candidates for FT. Our limitations include respondent's biases and that the participants of this consensus may not represent the larger medical community. Conclusions: FT can be offered to men coming off AS between the age of 60 to 80 with grade group 2 localized cancer. This consensus from a multidisciplinary, multi-institutional, international expert panel provides a contemporary insight utilizing FT for CaP in select patients who are discontinuing AS.